Opioid Update

Federation of State Medical BoardsModel Policy on the Use of Opioid

Analgesics in the Treatment of Chronic Pain

July 2013

FSMB Revised Model Policy-Introduction

• Updated Model Policy reflects considerable body of research and experience accrued since the 2004 revision was adopted.

• Strives to provide framework for legitimate medical use of opioids while safeguarding against misuse and diversion.

• Acknowledges lack of adequate evidence as to effectiveness and safety of long-term opioid therapy.

FSMB Revised Model Policy-Introduction

• Encourage State Medical Boards to adopt a consistent policy regarding the treatment of pain, particularly chronic pain and to promote patient access to appropriate pain management and, if indicated, substance abuse and addiction treatment.

FSMB Revised Model Policy-Introduction

• >100,000 Americans suffer from chronic pain according to IOM.

• One in four patients seen in primary care setting suffers from pain so intense as to interfere with ADL’s.

• Inconsistent state policies either facilitate or impede ability and willingness of health professionals to prescribe and manage patents in pain.

FSMB Revised Model Policy-Introduction

• While acknowledging under-treatment exists, it must be understood that chronic pain often is intractable AND

• Current medical knowledge and therapies, including opioids, does not provide for complete elimination of pain in most cases AND

• Existence of persistent and disabling pain does not in and off itself constitute evidence of under-treatment.

Circumstances that contribute to both inadequate Treatment and Inappropriate prescribing of

opioids by physicians may include:

• Uncertainty or lack of knowledge of prevailing best clinical practices• Inadequate research regarding sources and

treatment of pain• Conflicting clinical guidelines• Concern of added scrutiny by regulatory

agencies

Circumstances that contribute to both inadequate Treatment and Inappropriate prescribing of

opioids by physicians may include:

• Prescribing promotes scrutiny• Physician misunderstanding of causes and

manifestations of addiction and dependence• Physician fear of causing addiction• Physician fear of patient deception/deceit• Inadequate physician education about

regulatory policies and processes.

Circumstances that contribute to both inadequate Treatment and Inappropriate prescribing of

opioids by physicians may include:

• Inadequate education about regulatory policies and processes.

• Prescribing w/o legitimate medical purpose.• The physician and/or patient misperception that

complete eradication of pain is an attainable goal that can be achieved without disabling adverse effects.

Physician’s duties include not only prescribing of opioid analgesics but

–Appropriate education of patients regarding secure storage of medications–Appropriate disposal once course of

treatment is completed. – Identify the possible “criminal patient” by

checking PDMP.

Patient Responsibilities

–Provide complete and accurate information.–Do not leave medication unsecured– Some may have unrealistic expectations –Many reasons to deviate from the plan,

intentionally or unintentionally.

“FSMB revised Model Policy makes it clear that the State Medical Board will consider inappropriate

management of pain, particularly chronic pain, to be a departure from accepted best clinical practices,

including, but not limited to the following”

1. Inadequate attention to initial assessment to determine if opioids are clinically indicated and to determine risk for that individual patient.

2. Inadequate monitoring during use of drug(s)3. Inadequate patient education and informed

consent

“FSMB revised Model Policy makes it clear that the State Medical Board will consider inappropriate

management of pain, particularly chronic pain, to be a departure from accepted best clinical practices,

including, but not limited to the following”

4. Unjustified dose escalation w/o attention to risks or alternatives

5. XS reliance on opioids, esp. high dose6. Not making use of tools for risk mitigation

Federal Controlled Substance Act of 1970

The CSA defines “lawful prescription” as one that is issued for legitimate medical purpose by a practitioner acting in the usual course of professional practice.

FSMB: For the purposes of this policy, inappropriate treatment of pain includes:– Non-treatment– Inadequate treatment– Overtreatment– Continued use of ineffective treatments

Responsibility for Appropriate Pain Management

– Use of opioids must be based on sound clinical judgment and current best clinical practice

– This must be appropriately documented– There must be demonstrable benefit to the

patient.– There must be a legitimate physician-patient

relationship– Medications must be appropriate to the diagnosis

Responsibility for Appropriate Pain Management

– Careful f/u and monitoring of response to tx-adjust according to nature of pain, response and risk.

– Demonstrate that therapy has been adjusted as needed

– Document referrals as necessary.– Medical management but reflect current

knowledge of evidence-based or best clinical practices.

Preventing Opioid Diversion and Abuse

– Physicians MUST incorporate safeguards into their practices to minimize the risk of misuse and diversion of opioid analgesics.

– The board will consider the unsafe or otherwise inappropriate treatment of pain to be a departure from best clinical practice.

– The goal is management of the patient’s pain while effectively addressing other aspects of patient functioning including physical, psychological, social and work-related factors mitigating risk of diffuse, abuse, diversion and overdose.

FSMB: Guidelines

– Understanding Pain– Patient evaluation and risk stratifications– Development of Treatment Plan and Goals– Informed Consent and Treatment Agreements– Initiating an Opioid Trial– Ongoing Monitoring and Adapting the treatment

plan– Periodic Drug Testing

FSMB: Guidelines

– Understanding Pain– Patient evaluation and risk stratifications– Development of Treatment Plan and Goals– Informed Consent and Treatment Agreements– Initiating an Opioid Trial– Ongoing Monitoring and Adapting the treatment

plan– Periodic Drug Testing

FSMB: Guidelines

– Understanding Pain– Patient evaluation and risk stratifications– Development of Treatment Plan and Goals– Informed Consent and Treatment Agreements– Initiating an Opioid Trial– Ongoing Monitoring and Adapting the treatment

plan– Periodic Drug Testing

FSMB: Guidelines

– Consultation and Referral– Discontinuing Opioid Therapy– Medical Records– Compliance with controlled substance Laws and

Regulations

FSMB: Universal Precautions

– Make a Dx with appropriate differential– Conduct pt. assessment, including risk for SUD– Discuss proposed tx plan with patient and obtain

informed consent– Have written tx agreement that sets forth

expectations and obligations of the patient and the doctor.

– Initiate an appropriate trial of opioid therapy, with or without adjunctive medications

FSMB: Universal Precautions

– Perform regular assessments of pain and function.– Reassess patient’s pain score AND level of Fn.– Regularly evaluate in terms of the 5 A’s: Analgesia,

Activity, Adverse effects, Aberrant behaviors and Affect

– Periodically review pain dx and any comorbid conditions, including SUD and adjust tx regimen accordingly

– Keep careful and complete records of the initial evaluation and each f/u visit